MalfunctionHNI
MST CAPSULE RETRACTOR
Received Mar 26, 2014
Report 3019924-2014-00010 · MDR key 3851282
Device
Generic name
Ophthalmic Retractor
Manufacturer
Microsurgical Technology, Inc.Model number
MCR-0001Catalog number
MCR-0001
Product problems
- Difficult to Remove
Patient
61 YR
- No Known Impact Or Consequence To Patient
Narrative
Description of Event or Problem
DURING CATARACT SURGERY ON A PATIENT WITH LOOSE ZONULES, AN MST CAPSULE RETRACTOR WAS THREADED ONTO A CAPSULAR TENSION RING AND HAD TO BE CUT IN ORDER TO BE REMOVED FROM THE EYE. THE SURGEON CUT THE LOOP PORTION OF THE RETRACTOR AND REMOVED BOTH PORTIONS FROM THE EYE WITHOUT IMPACT TO THE PATIENT. POST-OP THE PATIENT WAS DOING VERY WELL WITH UNCORRECTED 20/25 VISION AND HEALING NORMALLY WITH A CENTERED PCIOL IN A STABLE CAPSULAR BAG.
Additional Manufacturer Narrative
THIS INCIDENT WAS DISCOVERED DURING THE INVESTIGATION FOR REPORT #3019924-2014-00009.
Remedial action
- Patient Monitoring